Senior Regulatory Analyst (MD Licensed)

Job Summary

Supporting the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services, the part-time Senior Regulatory Analyst (MD Licensed) will manage compliance oversight by reviewing complaints and incident reports related to human subjects research, conducting assessments, and collaborating with Institutional Review Boards (IRBs) while working remotely.

Key responsibilities

• Serve as the primary contact for communications regarding complaints and incident reports, ensuring accuracy and regulatory significance
• Draft correspondence, case summaries, and status reports while presenting analyses and recommendations to leadership
• Track case statuses and ensure records management practices support transparency and audit readiness

Required qualifications

• Master's degree in public health, clinical research, health sciences, or a related field
• 8+ years of relevant experience in human subjects research protections and regulatory compliance
• Experience working with Institutional Review Boards (IRBs) and applying federal regulations governing human subjects research
• Proficiency in project management software and Microsoft Office productivity tools
• Demonstrated ability to prepare written analyses and maintain detailed records with high accuracy